eQMS for Biotech & Pharma

FDA 21 CFR 11
Quality by Design
ICH Q8, Q9, Q10
GxP

Biotech moves fast.
Compliance shouldn't slow you down.

Without control over your documentation, you risk delays, failed audits, and lost investor confidence. Cognidox is the lean eQMS that helps biotech startups bring order to complexity - streamlining GxP compliance, accelerating approvals, and building the foundation for long-term success.

Are manual workflows killing your momentum?

For biotech start-ups, compliance should be seamless and scalable to your specific needs.

Cognidox empowers you to:

Digitise and automate your document control strategy

Start smart. Scale fast.

If you’ve got the required document controls in place from the start, you won’t need to back-solve your compliance process to convince investors and auditors in the future.

Here are all the QMS tools you’ll need to automate and control the end-to-end quality management of your product from the outset. Cognidox helps you record and evidence your entire control strategy - from discovery to clinical research, regulatory approval and post-market surveillance.

Training management built in - not bolted on

Cognidox empowers you to deliver and track training as part of your quality system reporting.

Build role-specific learning paths to scale across teams and sites
Link training requirements directly to your SOPs
Automatically assign training when documents are published or updated
Create engaging training courses using multi-media tools
Track progress and completion with real-time dashboards and reporting
Audit-ready evidence of training history by user, role, and document

Standard features

Document control

Workflow automation

Training tools

Software validation

Compliant e-signatures

Quality modules

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Meet international regulatory requirements and standards

Meet the requirements of ICH Q8, Q9 and Q10; GxP; GAMP; FDA 21 CFR Part 11; EU GMP Annex 11.

Don’t let eQMS validation slow you down

Cognidox supports customer-led eQMS validation with full transparency and guidance. You retain control of your processes, while we provide the tools and documentation to help validate faster and with confidence.

All the support you need with no nasty surprises

Cognidox brings together all the tools for business management and compliance in one easy-to-use package. We’ll help you scale seamlessly with our modular approach and transparent pricing.

Ready to transform your biotech development process?

Cognidox is everything you need to digitise and automate your control strategy, ensuring your pharma and biotech products meet the highest quality standards. Discover how Cognidox can help innovate and accelerate the way you work.

A Guide to GxP

From GDocP to GMP: ensuring data integrity and process control for FDA, EMA, and ISO compliance

Download now

See what our customers say!

The entire process from demo, training and implementation has been wonderful. The acceptance of the tool within the organization was very fast and growing by the week! This is a very versatile product and is simple to use. The workflows are very powerful and helps build compliance to several standards with ease.

Prasanna, COO

We trust Cognidox - it is robust, and with a careful setup, it is almost impossible for us to break it inadvertently. Importantly, this helps focus us on value (document content) and less on administrative process. In contrast to some consultants, it is always available, has excellent value, scales with the team and is easy to manage.

Alaric Taylor, Co founder at Vesynta

The software is very intuitive and configurable. The Cognidox team is friendly and approachable, and understands our needs. All in all, a powerful offering.

David Ahern, CEO at Coalesce Product Development

Cognidox is by far the easiest eDMS/eQMS to use and scores with a full-equipped access, without the need to buy/install/grant access to different modules. In addition, Cognidox is independent of any file-type and does not use thrid-party "logic", such as MFiles or alike.

Guenter Duerr, Director at Capsero

Cognidox has transformed our QMS by having one easy-to-use system for all our teams to access, and is saving us time with the manual processes of document control and scheduling.

Claire Raeburn, Quality Compliance Manager at Tissue Solutions

The system is flexible and can easily be customised to your organisational needs. The price point makes it an option for small companies that could benefit from an eQMS but do not have the funds to go with the more popular packages.